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Alpha-2 Adrenergic Agonist

Onreltea ( Brimonidine) for Port-Wine Stain

Phase 3

Waitlist Available

Led By Elena Pope, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,4,8,12,16 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial aims to study the use of Onreltea gel to treat facial capillary malformations in children, which can lead to psychological discomfort if untreated. Follow-up visits will assess efficacy and safety of the proposed treatment. A placebo-controlled study is also being explored.

Eligible Conditions

Port-Wine Stain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,4,8,12,16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,4,8,12,16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,4,8,12,16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The change in the color of the capillary malformation using Chroma meter values (Δa, ΔE) at 12 weeks.

Secondary study objectives

Changes in CEA scores at 12, 16 weeks compared to baseline

Changes in the color of the lesion (Δa, ΔE) at each follow up visit including the last visit at 16 weeks compared to baseline

Changes in the iVAS at 12 and 16 weeks compared to baseline

+3 more

Other study objectives

Percentage difference in Chroma Meter values (L -relative light intensity, a - color saturation, b - color spectrum) between treated and untreated lesions (control)

Percentage of patients experiencing flare-up (defined as reoccurrence of the red discoloration) at the end of the study (16 weeks)

Predictors for a good response, defined as at least 50 % change in the erythema measured using Chroma Meter (a* after compared to a* before) at 12 weeks mark

Side effects data

From 2013 Phase 4 trial • 376 Patients • NCT02003534

Conjunctiva Hyperemia

100%

80%

60%

40%

20%

Study treatment Arm

0.15% Brimonidine Tartrate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Onreltea ( Brimonidine)Experimental Treatment1 Intervention

All the patients enrolled in the study will apply Onreltea ( Brimonidine 0.33%) gel on the affected skin area for 12 weeks (from Day 0 to Week 12 visit).

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